This invention relates to laryngeal mask airway devices (LMA-devices). Such devices are useful in facilitating lung ventilation in unconscious patients by forming a low pressure seal around the patient""s laryngeal inlet, avoiding the known harmful effects of the endotracheal tube, which forms a seal within the windpipe (trachea).
LMA-devices of the types disclosed in UK Patent Nos. 2111394 and 2205499 have become accepted items of equipment for rapidly and reliably establishing an unobstructed airway in a patient in emergency situations and in the administration of anaesthetic gases, and have found use in most countries of the world. A disadvantage associated with the use of such a mask is encountered in a patient who is at risk from vomiting or regurgitating stomach contents while unconscious since although the device forms a seal around the laryngeal inlet sufficient to permit artificial ventilation of the lungs, the seal is sometimes insufficient to prevent lung contamination during retching, vomiting or regurgitation.
A partial solution to this problem is disclosed in U.S. Pat. No. 4,995,388 in which reliance is made upon a combination of an improved peripheral continuity of seal pressure against the laryngeal inlet and the provision of a drainage tube to conduct gastric contents away from the laryngeal inlet. However, one embodiment of such a system is itself disadvantaged by the fact that the removal of such gastric discharges can be achieved only after the seal between the LMA device and the laryngeal inlet/oesophagus has been breached. Another embodiment provides for removal of gastric drainage without breaching the seal between the LMA device and laryngeal inlet/oesophagus, but this proved awkward to insert and caused throat irritation.
A more successful solution to this problem has been provided by the gastro-laryngeal mask airway device disclosed in U.S. Pat. No. 5,241,956 and European Patent 651664. In that device, a drainage tube passes through the posterior aspect of the mask and through the distal end of the inflatable cuff of the mask to open in alignment with the patient""s oesophagus. However, the drainage tube must be sufficiently rigid at its distal end to withstand the pressure within the inflated cuff and it has been found that this may make proper insertion of the deflated device into the patient""s throat more difficult than either necessary or desirable.
In a modified gastro-laryngeal mask airway device disclosed in International Patent Application WO 97/12680, provision is made for the distal half of the mask to be of softly compliant construction, and to ensure against collapse of the drainage tube when the cuff is inflated. Also, the mask has a flexible leading edge for facilitating correct insertion into the throat of the patient.
European Patent Application 796631 and U.S. Pat. No. 5,632,271 disclose an LMA device which further facilitates insertion into the throat of the patient, an LMA device includes a drainage tube, which opens into the distal tip of the mask, passes along the posterior aspect of the flexible airway tube and emerges from the mouth of the patient just below the upper incisor teeth. For practical purposes this device works well but has the following limitations.
A disadvantage of this back-to-back tube orientation is that it confers a degree of instability to the mask when the device is in place, permitting the possibility of loss of seal between the mask and laryngeal inlet. Another disadvantage of the back-to-back tube configuration is that it confers to the tubular elements of the device an undesirable degree of stiffness so that movements of the head and neck of the patient occasioned, for example, by surgical manipulation or positioning, may result in undue harmful pressure being exerted on the surrounding tissues of the upper airway passages.
Another disadvantage is that the inserting index finger tends to slip off the airway and drainage tube due to lack of purchase. A still further disadvantage is that the inserting index finger may be damaged by the teeth of the patient because of the greater combined diameter of the back-to-back tubes.
The present invention has as its overall objective to provide an LMA device of the types described above, i.e., incorporating means for draining gastric discharge from the region of the oesophageal inlet of the patient, which substantially avoids the disadvantages described above in relation to various of the known types of LMA-devices.
In accordance with the invention, this objective is achieved by first modifying the bowl of the mask such that its interior curvature has a significantly deeper shape than previous constructions. This is accomplished by either making the posterior wall or backplate of the mask to generally the same peripheral dimensions to permit its attachment to the posterior aspect of the inflatable cuff formation (in contrast to attachment to the inner rim or equator of the cuff formation), or by changing the cross section shape of the cuff so that its seam is placed at offset from the major or equatorial plane. Hence, the backplate is located substantially behind, i.e., posteriorly of the cuff and not, as previously, within the annulus of the cuff. The backplate edge, or rim, is attached roughly tangentially with respect to the roughly ring-shaped cross-section of the inflatable toroidal shape of the cuff annulus. It will be evident that with this construction, the depth of the bowl of the mask, i.e., the distance between the anterior aspect of the cuff when inflated and the anterior aspect of the backplate, will be greater than in previous constructions by approximately half the posterior-anterior dimension of the inflated cuff. Since most adult-size LMA devices have cuff inflation diameters in the range of 12 to 16 millimeters, it is clear that the additional bowl depth will be of the order of 6 to 8 millimeters. This additional bowl depth permits the gastric drain tube to be on the anterior surface of the backplate instead of running posteriorly as in previous designs, increasing the stability of the mask when installed in the throat of the patient and reducing the tendency of the installed device to migrate outwardly.
This anterior placement of the drain tube also eliminates the requirement to guard the aperture of the airway tube against obstruction by the anatomical structure known as the epiglottis. To prevent such obstruction, former cuffs were provided with paired parallel bars running across the airway aperture. These bars proved effective in preventing epiglottis obstruction but offered unwanted resistance to airflow and tended to obstruct passage of suction or inspection tubing. Anterior positioning of the drain tube allows it to act as an epiglottic prop, holding back the epiglottic rim from the floor of the mask and the airway port. The paired bars described above were not able to prevent obstruction occurring as a result of the epiglottic rim lying in contact with the bowl or floor of the mask. The anterior location of the drain tube in the present invention overcomes the problems of epiglottic misplacement more effectively than the previous design.
The second modification to the backplate is to replace the single tube-joint port adapted to accept the flexible airway tube with a double-barrelled port in which said ports are arranged side-by-side, that is to say laterally, permitting easy assembly of said side-by-side airway and drainage tubes. This provides better correspondence with the cross section space within the throat, the major axis of which runs laterally, and reduces stiffness and consequent pressure on the throat from movements of the head and neck of the patient. Also, the side-by-side adjacency reduces the pressure exerted on the drainage tube by the incisor teeth of the patient, and facilitates manufacturing since the portions of the tubes in the throat of the patient describe similar radii.
The double-barrelled tube-joint additionally provides a desirable locating point for the tip of the index finger used to insert the device, thus reducing possible slipping of the finger on the tube-joint. Also, the reduced transverse diameter in the vertical direction between the teeth of the patient resulting from the side-by-side adjacency of the drainage and airway tubes reduces possible injury to the finger from contact with the teeth.
A third modification to the backplate is the incorporation of a well or depression covering an area of approximately 3 square centimeters and having a 2 to 5 millimeters depth situated in the anterior surface of the backplate under the drain tube where it connects with the distal end of the drain port of the backplate. The well has the dual functions of permitting gas circulation and allowing secretions from the trachea to be drained away.
The LMA device of the invention is readily distinguished from the devices proposed hitherto in which the backplate of the mask has been located within the annulus of the inflatable cuff, and in which the gastric drainage tube has been routed across the posterior surface of the backplate.
According to the invention, therefore, there is provided a laryngeal mask airway device equipped for drainage of gastric discharge, the device comprising an inflatable main-cuff and a backplate having a laryngeal-side and a pharyngeal-side. The backplate also has an external tube-joint adjacent to the proximal end of the main-cuff. The backplate is hermetically bonded to the periphery of the main-cuff establishing separation between a laryngeal-chamber region and a pharyngeal region. A distally open evacuation tube includes a distal portion which longitudinally traverses the interior of the distal region of the main-cuff in sealed relation therewith for operative engagement and communication with the inlet of the oesophagus. The evacuation tube traverses the laryngeal-chamber region generally adjacent to the laryngeal-side of the backplate and passages through a proximally located tube-joint to the pharyngeal region. An airway tube also extends into the tube-joint for communication with an airway port to provide a flowpath between the airway tube and laryngeal-chamber region.
These and other objects, features, and advantages of the invention will be more fully understood from the following description of certain specific embodiments of the invention taken together with the accompanying drawings.